AS 5369-2023

Description

AS 5369 – 2023 Edition – Reprocessing of reusable medical devices and other devices in health and non-health related facilities

AS 5369 specifies requirements and practices for the effective and safe reprocessing, storage, handling and transportation of RMDs/other devices used in human health care and other treatments.

AS 5369 is applicable wherever RMDs/other devices are reprocessed in facilities, including for example, the reprocessing of RMDs/other devices used in post-mortem examinations.

The application of the principles of this document recognizes and acknowledges that there are similarities and differences between different types of facilities (e.g. hospitals, medical imaging practices, office-based practices including medical clinics, dental practices, podiatry practices, aesthetics and body modification practices).

The similarities are the common need for quality systems, staff training and competency, and conformance to reprocessing procedures. The main differences relate to the physical and organizational conditions in different types of facilities (e.g. reprocessing equipment and ability to physically segregate the reprocessing environment).

The principles of this document also apply to processing of single-use RMDs/other devices supplied to facilities in a non-sterile state and which require sterilization in accordance with the device’s processing instructions prior to single use.

The principles of infection prevention and control preclude the interchange of RMDs/other devices between live patient/client health care (including harvesting of organs after brain death) and RMDs/other devices in any of the following activities:

(a) autopsy, post-mortem examinations, anatomy dissections of deceased persons, mortuary care and embalming;
(b) veterinary procedures; and
(c) preclinical training using animal or removed human tissue (e.g. extracted teeth).

AS 5369 therefore does not contain requirements for RMDs/other devices used in any of these activities.
The principles of this document may be applied to the reprocessing of RMDs/other devices used in veterinary practice.

General Product Information:

Edition	1st Edition
Document Type	PDF
Document Language	English
Committee	HE-023
ISBN	9781761394690
Pages	144
Publisher	Standards Australia(AS)
Status	Current